K Number
K060914
Device Name
TRIDENT ANCHOR
Date Cleared
2006-06-09

(66 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trident Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment
Device Description
The Trident Anchor System includes the Trident Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with or without a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The Anchor could be provided with a variety of #2 suture options.
More Information

Not Found

No
The summary describes a mechanical surgical anchor system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Yes
The device, Trident Anchor, is used in various surgical repairs and reattachments (e.g., Rotator Cuff Repair, Biceps Tenodesis), indicating a therapeutic purpose to treat or alleviate a medical condition.

No
The text indicates that the device is a "Trident Anchor System" used for "Rotator Cuff Repair, Biceps Tenodesis" and other ligament/tendon repairs. This describes a surgical implant used for treatment/repair, not for diagnosing conditions.

No

The device description clearly states that the Trident Anchor System includes physical components such as the anchor, inserter shaft, anvil, threader tab, suture, and a reusable Deployment Gun. These are hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes surgical procedures performed on the body (Shoulder, Knee, Elbow repairs and reattachments). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description: The device is a surgical anchor and its associated delivery system, designed to be implanted in the body. This is consistent with a surgical device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, the Trident Anchor is a surgical implant/device, not an IVD.

N/A

Intended Use / Indications for Use

Trident Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Product codes (comma separated list FDA assigned to the subject device)

MBI, HWC

Device Description

The Trident Anchor System includes the Trident Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with or without a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The Anchor could be provided with a variety of #2 suture options.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Knee, Elbow

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Trident Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K970089, K971922, K051219, K042914

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

0

K060914 Page 1 of 2

SECTION 2 – 510(k) SUMMARY

Trident AnchorJUN - 9 2006
Submitter's Name and
Address:DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Contact PersonRuth C. Forstadt
Project Management Lead, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone:
508-977-3988
Facsimile:
508-828-3750
e-mail:rforstad@dpyus.jnj.com
Name of Medical DeviceClassification Name:Fastener, Fixation, Nondegradable, Soft
Tissue Smooth or threaded metallic bone
fixation fasteners
Common/Usual Name:
Proprietary Name:Bone Anchor
Trident Anchor
Substantial EquivalenceTrident Anchor is substantially equivalent to:
ROC EZ Fastener (K970089 & K971922); the Arthrex Pushlock
Anchor (K051219) and the ArthroCare Opus Magnum Implant
(K042914).
Device ClassificationThis device carries an FDA product code MBI and HWC, and is
classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or
threaded metallic bone fixation fasteners under 21 CFR 888.3040.
Device DescriptionThe Trident Anchor System includes the Trident Anchor, which will be
presented sterile, pre-mounted on an inserter shaft w/anvil with or
without a threader tab and suture. The System will be deployed with
the use of a reusable Deployment Gun. The Anchor could be provided
with a variety of #2 suture options.
Premarket Notification: TraditionalConfidential

Premarket Notification: Traditional Trident Anchor

.

:

1

| Indications for Use | Trident Anchor is indicated for use in the following:
Shoulder: Rotator Cuff Repair, Biceps Tenodesis
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Joint Capsule Closure
Elbow: Biceps Tendon Reattachment |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Performance | Results of performance and safety testing have demonstrated that the
modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and
comparison to predicate devices, the Trident Anchor has been shown to
be substantially equivalent to predicate devices under the Federal Food,
Drug and Cosmetic Act. |

.

Confidential

.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2006

DePuy Mitek a Johnson & Johnson Co. % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K060914

Trade/Device Name: Trident Anchor Regulation Code: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC, MBI Dated: April 3, 2006 Received: April 4, 2006

Dear Ms. Forstadt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

3

Page 2 -- Ms. Ruth C. Forstadt

CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Page Of

510(k) Number (if known): K660914

Device Name: Trident Anchor

Trident Anchor is indicated for use in the following:

Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Prescription Use

OR

Over-the -Counter Use No
(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

Division Sign-Off) Division of General, Restorative and Neurological Devices

Number K06 09/4